Cytokinetics, Inc. Announces First Patient Dosed in Cohort 2 of Redwood-HCM
January 13, 2021 at 07:30 am
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Cytokinetics Inc. announced that the first patient has been dosed in Cohort 2 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), an ongoing Phase 2 clinical trial of CK-3773274 (CK-274), a next-generation cardiac myosin inhibitor in development for the potential treatment of hypertrophic cardiomyopathy (HCM). This event triggers a $2.5 million milestone payment payable from Ji Xing Pharmaceuticals Limited to Cytokinetics under the License and Collaboration Agreement between the companies. REDWOOD-HCM: Clinical Trial Design: REDWOOD-HCM is a multi-center, randomized, placebo-controlled, double-blind, dose finding clinical trial of CK-274 in patients with symptomatic obstructive HCM (oHCM). The primary objective of the trial is to determine the safety and tolerability of CK-274. The secondary objectives are to describe the concentration-response relationship of CK-274 on the resting and post-Valsalva left ventricular outflow tract gradient as measured by echocardiography during 10 weeks of treatment, to describe the dose response relationship of CK-274, and to evaluate the plasma concentrations of CK-274 in patients with oHCM. The trial will enroll two sequential cohorts, with an option for a third cohort. Within each cohort, approximately 18 patients will be randomized 2:1 to active or placebo treatment and receive up to three escalating doses of CK-274 or placebo based on echocardiographic guidance. Patients receive an echocardiogram after two weeks of treatment at each dose to determine whether they will be up-titrated. Overall, the treatment duration will be 10 weeks with an echocardiogram to confirm reversibility of effect 2-weeks after the last dose. REDWOOD-HCM is expected to enroll patients in approximately 20 investigative sites in North America and Europe. Interim analysis of data from Cohort 1 of REDWOOD-HCM showed patients experienced substantial reductions in the average resting left ventricular outflow tract gradient (LVOT-G) as well as the post-Valsalva LVOT-G (defined as resting gradient <30 mmHg and post-Valsalva gradient <50 mmHg). These clinically relevant decreases in pressure gradients were achieved with only modest decreases in average left ventricular ejection fraction (LVEF); there were no dose interruptions due to LVEF falling below 50%, the prespecified safety threshold. Pharmacokinetic data were similar to those observed in Phase 1 in healthy subjects. In addition, the safety and tolerability data were supportive of continued dose escalation with no serious adverse events attributed to study treatment reported by the investigators. The second cohort of REDWOOD-HCM is open for enrollment in centers in North America and Europe. Enrollment in Cohort 2 of REDWOOD-HCM is expected to complete in first quarter of 2021 and full results from REDWOOD-HCM, across both Cohort 1 and Cohort 2, are expected in mid-2021.
Cytokinetics, Incorporated is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. The Company specializes in muscle biology and the mechanics of muscle performance. It is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Its cardiac muscle contractility program is focused on the cardiac sarcomere. Its clinical-stage drug candidates are: aficamten, which is a next-in-class cardiac myosin inhibitor; omecamtiv mecarbil, which is a cardiac myosin activator; CK-586, which is an additional cardiac myosin inhibitor, and CK-136, which is a cardiac troponin activator. CK-586 is designed to reduce the hypercontractility associated with heart failure with preserved ejection fraction.
CYTOKINETICS, INCORPORATED 
